Events

Alerta De Seguridad para Ellipse VR/DR Implantable Cardioverter Defibrillators

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por St. Jude Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-08-20
  • Fecha de publicación del evento
    2014-08-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140820a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: st. jude medical ellipse vr/dr implantable cardioverter defibrillators the australia therapeutic goods administration (tga) posted a medical device safety alert concerning ellipse vr/dr implantable cardioverter defibrillators (icds) manufactured by st. jude medical. the affected models are cd1277 (-36 and -36q), cd1377 (-36, -36q, -36c and -36qc), cd2277 (-36 and -36q) and cd2377 (-36, -36q, -36c and -36qc). icds with serial numbers beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected. the manufacturer has received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value. this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock. according to the manufacturer, there have been no reported cases of an ellipse device failing to deliver high voltage therapy to a patient when needed. the manufacturer is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with the affected devices. furthermore, the manufacturer advises customers that the affected stock will be retrieved and replaced by new ellipse icds with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole. for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00905-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2014.

Device

Ellipse VR/DR Implantable Cardioverter Defibrillators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH